Wellness Achieved Through Changing Habits (WATCH): An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

通过改变习惯实现健康（WATCH）：针对不同青少年的基于接受的健康生活方式干预

• 批准号: 10738846
• 负责人: Stephanie Manasse
• 金额: $ 71.47万
• 依托单位: DREXEL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-09 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10738846
• 关键词: 19 year old; Accelerometer; Adherence; Adolescent; Adult; Affect; Aftercare; Anorexia; Behavior Therapy; Behavioral; Biological; Blood Pressure; Body Composition; Body Weight decreased; Body fat; Body mass index; Cardiometabolic Disease; Clinical Trials; Cues; Demographic Factors; Development; Devices; Diet; Dietary intake; Disinhibition; Eating Behavior; Eating Disorders; Educational process of instructing; Effectiveness; Emotions; Ethnic Origin; Exhibits; Feasibility Studies; Female Adolescents; Foundations; Goals; Habits; Health; Health behavior; Hour; Hybrids; Hyperphagia; Informal Social Control; Institutional Review Boards; Intervention; Maintenance; Manuals; Measures; Mediating; Mental Depression; Meta-Analysis; Modality; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Outcome; Outpatients; Overweight; Participant; Patient Recruitments; Perceived quality of life; Persons; Phase; Physical activity; Physiological; Policies; Population Heterogeneity; Prevention; Procedures; Progress Reports; Psychological Factors; Quality of life; Race; Randomized; Randomized, Controlled Trials; Remote session; Risk Factors; Sleep; Socioeconomic Status; Teacher Professional Development; Testing; Therapeutic Intervention; Time; Time Study; United States; United States National Institutes of Health; Weight; Work; acceptability and feasibility; anxiety sensitivity; behavioral outcome; blood lipid; blood pressure reduction; cardiometabolism; cardiovascular disorder risk; chronic pain; community clinic; craving; demographics; dietary; efficacy testing; enhanced care; ethnic minority; experience; feasibility testing; flexibility; follow-up; girls; healthy lifestyle; high risk; high risk sexual behavior; improved; individualized medicine; innovation; intervention effect; lifestyle intervention; mindfulness; novel; obesity treatment; operation; primary outcome; psychologic; psychological outcomes; racial diversity; racial minority; recruit; restraint; secondary outcome; sedentary lifestyle; skills; standard care; success; therapy development; tool; treatment comparison; trial comparing; weight loss intervention

ABSTRACT Overweight/obesity (OW/OB) affects 14 million adolescents in the United States, disproportionately affecting girls and racial/ethnic minorities, increasing their risk of cardiovascular disease and type 2 diabetes. Behavioral weight loss interventions are the foundation of obesity treatment modalities, yet many have led to limited weight loss and weight regain is common. Limited success in adolescent weight loss interventions may be attributed primarily to adolescents’ lack of self-regulation skills, which are essential for adhering to diet and physical activity goals. There is a critical need for development of interventions that teach self-regulation skills to adolescents in order to adapt to pervasive biological and environmental cues that are often experienced during weight loss. An innovative behavioral treatment, acceptance-based therapy (ABT), focuses on self- regulation skills and increasing mindfulness and tolerance of negative or uncomfortable emotions. ABT has demonstrated strong evidence as an effective weight loss strategy in adults. Our group utilized an adolescent- engaged approach to develop, implement, and test the feasibility and acceptability of an ABT weight loss intervention for adolescent girls with OW/OB. The feasibility study was a 6-month ABT behavioral weight loss intervention comprised of 15 in-person group sessions (90-minutes each) over a 6-month period led by an instructor trained in ABT. The feasibility study demonstrated strong acceptability among adolescent girls with OW/OB. The objective of this study, called the Wellness Achieved Through Changing Habits (WATCH) trial, is to test the efficacy of an ABT intervention versus an enhanced care (EC) intervention on markers of cardiometabolic health, health related behaviors, and psychological factors. During the R61 phase (year one), we will finalize all WATCH policies and procedures including clinical trials registration, manual of operations, IRB approvals, convening the DSMB board, and begin recruitment. We will also submit a NIH progress report on participant recruitment, demographics, and intervention fidelity. During the R33 phase (years 2-5), we propose a randomized controlled trial of 148 adolescent girls (≥40% racial/ethnic minorities) with OW/OB to test the hypothesis that those randomized to ABT (vs. EC) will have significantly decreased BMI z-score (primary outcome) and body fat, and improved blood pressure and blood lipids at post-treatment, 6-month follow-up, and 12-month follow-up. We also hypothesize that relative to EC intervention, ABT will significantly improve health-related behaviors and psychological factors. As an exploratory aim, we will examine the extent to which ABT’s effects on weight and body composition are mediated by improvements in behavioral and psychological factors, and identify key moderators of ABT intervention effects including baseline demographic and psychological factors. This study will yield a novel, obesity intervention tailored to the needs of adolescents with OW/OB by developing self-regulation skills and providing tools to promote cardiometabolic health.

摘要 超重/肥胖（OW/OB）影响着美国1400万青少年， 女孩和种族/少数民族，增加了他们患心血管疾病和2型糖尿病的风险。行为 减肥干预措施是肥胖治疗方式的基础，但许多措施导致了有限的 体重减轻和体重恢复是常见的。青少年减肥干预的有限成功可能是 这主要归因于青少年缺乏自我调节技能，而自我调节技能对于坚持饮食和 身体活动目标。迫切需要制定干预措施，教授自我调节技能 为了适应普遍的生物和环境线索， 在减肥过程中。一种创新的行为治疗方法，即基于接受的治疗（ABT），重点关注自我 调节技能和增加正念和容忍消极或不舒服的情绪。ABT拥有 证明了强有力的证据，作为一个有效的减肥策略在成年人。我们组利用一个青少年- 参与的方法来开发，实施和测试ABT减肥的可行性和可接受性 对患有OW/OB的少女进行干预。可行性研究是为期6个月的ABT行为减肥 干预包括15个面对面的小组会议（每次90分钟），为期6个月，由一名 接受过ABT培训的教师。可行性研究表明， OW/OB这项研究的目的，所谓的健康实现通过改变习惯（观看）试验，是 为了测试ABT干预与加强护理（EC）干预对以下指标的有效性， 心脏代谢健康、健康相关行为和心理因素。在R61阶段（第一年）， 我们将最终确定所有WATCH政策和程序，包括临床试验注册，操作手册， IRB批准，召开DSMB委员会，并开始招募。我们还将提交一份NIH进展报告 参与者招募，人口统计学和干预保真度。在R33阶段（2-5年），我们 提出一项在148名患有OW/OB的青春期女孩（≥40%种族/少数民族）中进行的随机对照试验， 检验随机分配至ABT（vs. EC）组的患者BMI z评分显著降低的假设 （主要结局）和体脂，以及治疗后6个月时血压和血脂改善 随访和12个月随访。我们还假设，相对于EC干预，ABT将显着 改善健康相关行为和心理因素。作为一个探索性的目标，我们将研究 ABT对体重和身体组成的影响是通过改善行为和 心理因素，并确定ABT干预效果的关键调节因素，包括基线人口统计学 和心理因素。这项研究将产生一种新的，针对青少年需求的肥胖干预措施 通过发展自我调节技能和提供促进心脏代谢健康的工具，与OW/OB合作。